Editorial: Legwork needed to ensure drug safety

Regulators, providers must step up after meningitis outbreak.

October 13, 2012 — 9:11pm

Uncredited, Associated Press - ApThis photo provided Oct. 9, 2012, by the Minnesota Department of Health shows shows vials of the injectable steroid product made by New England Compounding Center implicated in a fungal meningitis outbreak that were being shipped to the Centers for Disease Control and Prevention in Atlanta from Minneapolis. About 17,700 single-dose vials of the steroid sent to 23 states have been recalled. The outbreak involves 10 states, including Minnesota.

A clinic's name doesn't appear alongside the drug manufacturer's on medication packages or vials. But it might as well be printed there.

From a patient's perspective, there's an inherent clinic seal of approval on medications given during medical treatment. Those seeking care understandably assume that the drugs swallowed, injected or distributed on the premises have been purchased from reputable suppliers.

But a deadly meningitis outbreak linked to a pharmacy firm essentially operating as a drug manufacturer suggests that this trust in providers has sometimes been misplaced. While federal oversight should be strengthened, medical practice boards and professional associations in Minnesota and elsewhere must do more to ensure that providers know how to spot and root out potentially risky suppliers.

The meningitis outbreak has so far sickened 170 people in 11 states, with three of the cases in Minnesota. Fourteen people have died.

According to the U.S. Centers for Disease Control and Prevention, the illnesses are associated with a "potentially contaminated" injectable steroid medication manufactured by the Massachusetts-based New England Compounding Center. The injections were typically used for back pain. More than 17,000 vials were shipped to 75 clinics in 18 states, the New York Times reported.

The outbreak has put an overdue spotlight on large "compounding" pharmacies that have branched far beyond the traditional, respected niche of customizing medications on an individual basis (such as adding flavor to a child's medication or mixing a dye-free version of a brand-name drug) to producing much larger volumes of pharmaceuticals.

FOR MORE INFO

The latest statistics and updates about the meningitis outbreak are available from the U.S. Centers for Disease Control and Prevention. To learn more, go to www.startribune.com/a1794.

These firms essentially are acting as drug manufacturers. But their status as compounding pharmacies creates uncertainty about where states' historic authority over professional practices (such as pharmacists) ends and where federal authority over drug manufacturing begins. While Congress passed a law in 1997 giving explicit authority over compounding pharmacies to the U.S. Food and Drug Administration, those measures were mostly struck down by a 2002 U.S. Supreme Court decision.

Congress has done nothing since then to remedy the situation, even as additional court action has further muddied the agency's authority. FDA funding challenges also make it a difficult for the agency to police small, under-the-radar manufacturers.

But providers also share responsibility for supplier oversight, and they need to do better. Last week, the Star Tribune's Maura Lerner reported that the New England Compounding Center was not licensed in Minnesota to sell in bulk. Yet it had shipped hundreds of vials of contaminated product to the state.

The state Board of Pharmacy has made it clear for several years that it will not tolerate Minnesota-based pharmacy compounders selling in bulk. Its concerns have also prompted it to give greater scrutiny to out-of-state pharmacies who want a license here.

Providers need to follow the board's active lead. At a minimum, clinic staff should make sure that drugs are purchased from properly licensed suppliers, especially when dealing with a new or smaller firm.

A phone call or an e-mail inquiry is likely all that's needed to verify this. A quick search of the FDA website could also turn up warning letters or other concerns.

This is basic but critical legwork. The state's leading medical organizations need to send a clear message to providers that this backgrounding is a high priority.